JP6119609B2 - Hollow needle-like body manufacturing method, hollow needle-like body and hollow needle-like body liquid feeding system - Google Patents

Hollow needle-like body manufacturing method, hollow needle-like body and hollow needle-like body liquid feeding system Download PDF

Info

Publication number
JP6119609B2
JP6119609B2 JP2013540732A JP2013540732A JP6119609B2 JP 6119609 B2 JP6119609 B2 JP 6119609B2 JP 2013540732 A JP2013540732 A JP 2013540732A JP 2013540732 A JP2013540732 A JP 2013540732A JP 6119609 B2 JP6119609 B2 JP 6119609B2
Authority
JP
Japan
Prior art keywords
needle
hollow
acicular
groove
substrate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2013540732A
Other languages
Japanese (ja)
Other versions
JPWO2013061825A1 (en
Inventor
杉村 浩
浩 杉村
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Toppan Inc
Original Assignee
Toppan Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Toppan Inc filed Critical Toppan Inc
Publication of JPWO2013061825A1 publication Critical patent/JPWO2013061825A1/en
Application granted granted Critical
Publication of JP6119609B2 publication Critical patent/JP6119609B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C67/00Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0038Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a channel at the side surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053Methods for producing microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/04Skin

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Composite Materials (AREA)
  • Chemical & Material Sciences (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Micromachines (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

本発明は、中空針状体の製造方法およびそれによって製造された中空針状体に関する。   The present invention relates to a method for producing a hollow needle-like body and a hollow needle-like body produced thereby.

経皮吸収法は、皮膚上から薬剤などの送達物を浸透させて人体内に送達物を投与する方法である。この方法は、人体に痛みを与えることなく簡便に送達物を投与することができる。   The percutaneous absorption method is a method in which a delivery product such as a drug is permeated from above the skin to administer the delivery product into the human body. In this method, the delivery product can be easily administered without causing pain to the human body.

経皮投与の分野において、μmオーダーの針が形成された針状体を用いて皮膚に穿刺し、薬剤などを投与する方法が提案されている(特開昭48−93192号公報参照)。   In the field of transdermal administration, there has been proposed a method of puncturing the skin using a needle-like body on which a needle of the order of μm is formed and administering a drug or the like (see Japanese Patent Laid-Open No. 48-93192).

また、μmオーダーの針が形成された針状体において、中空部を備えることにより該中空部を通して送達物を投与することが提案されている(米国特許第3964482号明細書参照)。   In addition, it has been proposed that a delivery object is administered through a hollow part by providing the hollow part in a needle-like body in which a needle of μm order is formed (see US Pat. No. 3,964,482).

機械加工を用いて原版を作製すること、この原版から転写版を形成すること、この転写版を用いて転写加工成型を行なうことを含む針状体の製造方法が提案されている(国際公開第2008/013282号パンフレット参照)。   There has been proposed a method for manufacturing a needle-like body, which includes producing an original plate using machining, forming a transfer plate from the original plate, and performing transfer processing molding using the transfer plate (International Publication No. 1). 2008/013282 pamphlet).

エッチング法を用いて原版を作製すること、この原版から転写版を形成すること、この転写版を用いて転写加工成型を行なうことを含む針状体の別の製造方法が提案されている(国際公開第2008/004597号パンフレット参照)。   Another method for producing a needle-like body has been proposed, including producing an original plate using an etching method, forming a transfer plate from the original plate, and performing transfer processing molding using the transfer plate (International (See Publication No. 2008/004597 pamphlet).

針状体を構成する材料は、針状体が仮に破損し、人体内に残留した場合でも、人体に悪影響を及ぼさない材料であることが望ましい。このため、針状体の材料にはキチン、キトサン等の生体適合材料を用いることが提案されている(国際公開第2008/020632号パンフレット参照)。   The material constituting the acicular body is desirably a material that does not adversely affect the human body even if the acicular body is damaged and remains in the human body. For this reason, it has been proposed to use biocompatible materials such as chitin and chitosan as the material for the needle-like body (see International Publication No. 2008/020632 pamphlet).

従来の中空針状体の製造方法は、多くの工程と時間を費やさなければならず、量産性に乏しい問題がある。特に、複数の針が配列された中空針状体を製造する場合には、各針の中空部を精度良く配置して形成することが困難である。   A conventional method for producing a hollow needle-like body has to spend many steps and time, and has a problem of poor mass productivity. In particular, when manufacturing a hollow needle-like body in which a plurality of needles are arranged, it is difficult to accurately arrange and form the hollow portions of the needles.

また、量産性に優れた射出成形などの転写成形法を用いて中空針状体を製造する場合、細長い金型を用いて中空構造を微細な針状体の内部に形成する必要がある。しかしながら、中空構造形成用の金型を針状体構造金型内部に精度良く配置することは困難である。細長い中空構造形成用の金型は強度が低いため、金型寿命が短い問題がある。さらに、中空針状体の成形後に細長い中空構造形成用金型を成形品から引き抜く工程においても、金型が破損しやすい問題がある。   Further, when a hollow needle-shaped body is manufactured using a transfer molding method such as injection molding with excellent mass productivity, it is necessary to form a hollow structure inside a fine needle-shaped body using an elongated mold. However, it is difficult to accurately arrange the mold for forming the hollow structure within the needle-shaped structure mold. Since the mold for forming an elongated hollow structure has low strength, there is a problem that the mold life is short. Furthermore, there is a problem that the mold is easily damaged in the process of pulling out the elongated hollow structure forming mold from the molded product after the hollow needle-shaped body is molded.

本発明は、中空針状体を分割した、表面に溝を有する第1の針状体基材と被覆部材を作製し、第1の針状体基材の溝を含む面に被覆部材を覆うことによって、被覆部材で囲まれた溝を中空部として有する中空針状体を簡便かつ量産的に製造可能な方法、およびそれによって製造された中空針状体を提供することを目的とする。   The present invention produces a first acicular body substrate and a covering member having a groove on the surface, which is obtained by dividing a hollow acicular body, and covers the covering member on a surface including the groove of the first acicular body substrate. Accordingly, an object of the present invention is to provide a method capable of easily and mass-producing a hollow needle-like body having a groove surrounded by a covering member as a hollow portion, and a hollow needle-like body produced thereby.

上記課題を解決するため、本発明の第1の態様によると、内部に中空部を有する中空針状体を製造する方法であって、表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材を作製する工程と、前記第1の針状体基材の溝を含む面を被覆部材で覆う工程と、を含み、前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成する第2の針状体基材であり、前記第1の針状体基材および前記第2の針状体基材の夫々は、針状体部と、前記針状体部をその基底部において保持する基板部とを備え、前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、中空針状体の製造方法が提供される。
本発明の第2の態様によると、内部に中空部を有する中空針状体を製造する方法であって、表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材を作製する工程と、前記第1の針状体基材の溝を含む面を被覆部材で覆う工程と、を含み、前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成するシート状部材であり、前記第1の針状体基材は、針状体部と、前記針状体部をその基底部において保持する基板部とを備え、前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、中空針状体の製造方法が提供される。
In order to solve the above-mentioned problem, according to the first aspect of the present invention, there is provided a method for producing a hollow needle-like body having a hollow portion therein, the surface having a groove constituting at least a part of the hollow portion. a step of preparing a first needle-like base material, a step of covering a surface including the groove of the first needle-like base material with a coating member, only containing the covering member, the first needle A second needle-like body base material constituting the hollow needle-like body in combination with a needle-like body base material, and each of the first needle-like body base material and the second needle-like body base material is a needle And a substrate part for holding the needle-like body part at its base part, and the groove of the first needle-like body base is formed in the needle-like body part and the substrate part. There is provided a method for manufacturing a hollow needle-like body , wherein the groove of the substrate portion is connected to the groove of the needle-like body portion .
According to a second aspect of the present invention, there is provided a method for producing a hollow needle-like body having a hollow portion therein, the first needle-like body base having a groove constituting at least a part of the hollow portion on the surface. And a step of covering a surface including the groove of the first acicular body substrate with a covering member, the covering member being combined with the first acicular body substrate, A sheet-like member constituting a hollow needle-like body, wherein the first needle-like base material includes a needle-like body portion and a substrate portion that holds the needle-like body portion at a base portion thereof, A hollow needle-like shape in which the groove of one needle-like base material is formed in the needle-like body portion and the substrate portion, and the groove of the substrate portion is connected to the groove of the needle-like body portion. A method of manufacturing a body is provided.

本発明の第の態様によると、空部を有する針状体部を備える中空針状体であって、表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材と、前記第1の針状体基材の溝を含む面を覆う被覆部材と、を備え、前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成する第2の針状体基材であり、前記第1の針状体基材および前記第2の針状体基材の夫々は、針状体部と、前記針状体部をその基底部において保持する基板部と、を備え、前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、中空針状体が提供される。
本発明の第4の態様によると、中空部を有する針状体部を備える中針状体であって、表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材と、前記第1の針状体基材の溝を含む面を覆う被覆部材と、を備え、前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成するシート部材であり、前記第1の針状体基材は、針状体部と、前記針状体部をその基底部において保持する基板部と、を備え、前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、中空針状体が提供される。
本発明の第5の態様によると、第3又は第4の態様に係る中空針状体と、この中空針状体の中空部に連結された液体の押し出し手段および吸引手段の少なくとも一方の手段と、を具備する中空針状体送液システムが提供される。
According to a third aspect of the present invention, a hollow needle body having a needle-like body portion having a middle empty section, the first needle-like member having a groove which constitutes at least a part of the hollow portion on the surface A base member, and a covering member that covers a surface including the groove of the first acicular body base material, and the covering member combines the first acicular body base material with the hollow needle-like body. A second acicular body base material, wherein each of the first acicular body base material and the second acicular body base material includes a acicular body portion and a base of the acicular body portion. A substrate portion held by the portion, wherein the groove of the first acicular body base is formed in the acicular body portion and the substrate portion, and the groove of the substrate portion is the acicular body A hollow needle-like body connected to the groove of the portion is provided.
According to a fourth aspect of the present invention, it is empty needles in comprising a needle-like body portion having a hollow portion, the first needle-like member having a groove which constitutes at least a part of the hollow portion on the surface A base member, and a covering member that covers a surface including the groove of the first acicular body base material, and the covering member combines the first acicular body base material with the hollow needle-like body. The first needle-like body base material includes a needle-like body portion, and a substrate portion that holds the needle-like body portion at a base portion thereof. A hollow needle-like body is provided in which the groove of the substrate is formed in the needle-like body portion and the substrate portion, and the groove of the substrate portion is connected to the groove of the needle-like body portion. .
According to the fifth aspect of the present invention, the hollow needle-like body according to the third or fourth aspect, and at least one of the liquid pushing means and the suction means connected to the hollow portion of the hollow needle-like body, , A hollow needle-like body liquid feeding system is provided.

図1は、本発明の実施形態に係る中空針状体を製造するための、溝を形成する前の第1の針状体基材の種々の例を示す斜視図である。Drawing 1 is a perspective view showing various examples of the 1st acicular body substrate before forming a slot for manufacturing a hollow acicular body concerning an embodiment of the present invention. 図2は、本発明の実施形態に係る中空針状体を製造するための、溝を有する第1の針状体基材の種々の例を示す斜視図である。Drawing 2 is a perspective view showing various examples of the 1st acicular body substrate which has a slot for manufacturing a hollow acicular body concerning an embodiment of the present invention. 図3は、本発明の第1の実施形態に係る中空針状体の製造工程を示す斜視図である。FIG. 3 is a perspective view showing a manufacturing process of the hollow needle-like body according to the first embodiment of the present invention. 図4は、本発明の第2の実施形態に係る中空針状体の製造工程を示す斜視図である。FIG. 4 is a perspective view showing a manufacturing process of the hollow needle-like body according to the second embodiment of the present invention. 図5は、本発明の第3の実施形態に係る中空針状体の嵌合構造を説明するための斜視図である。FIG. 5 is a perspective view for explaining the hollow needle-like fitting structure according to the third embodiment of the present invention. 図6は、本発明の第4の実施形態に係る中空針状体の製造工程を示す斜視図である。FIG. 6: is a perspective view which shows the manufacturing process of the hollow acicular body which concerns on the 4th Embodiment of this invention. 図7は、本発明の第5の実施形態に係る中空針状体の製造工程を示す斜視図である。FIG. 7: is a perspective view which shows the manufacturing process of the hollow acicular body which concerns on the 5th Embodiment of this invention. 図8は、本発明の第6の実施形態に係る中空針状体アレイ構造の一例を示す斜視図である。FIG. 8 is a perspective view showing an example of a hollow needle array structure according to the sixth embodiment of the present invention. 図9は、本発明の第7の実施形態に係る中空針状体の製造工程を示す斜視図である。FIG. 9 is a perspective view showing a manufacturing process of the hollow needle-like body according to the seventh embodiment of the present invention. 図10は、本発明の第7の実施形態に係る中空針状体アレイ構造の一例を示す斜視図である。FIG. 10 is a perspective view showing an example of a hollow needle array structure according to the seventh embodiment of the present invention.

以下、本発明の実施形態に係る中空針状体の製造方法および中空針状体を詳細に説明する。   Hereinafter, the manufacturing method of a hollow needlelike object and a hollow needlelike object concerning an embodiment of the present invention are explained in detail.

実施形態に係る中空針状体の製造方法は、内部に中空部を有する中空針状体を製造する方法であって、表面に中空部の少なくとも一部を構成する溝を有する第1の針状体基材を作製すること、第1の針状体基材の溝を含む面を被覆部材で覆うことを含む。   The method for producing a hollow needle-like body according to the embodiment is a method for producing a hollow needle-like body having a hollow portion therein, and the first needle-like shape having a groove constituting at least a part of the hollow portion on the surface. Producing a body base material, and covering the surface including the groove of the first acicular body base material with a covering member.

実施形態に係る中空針状体の製造方法は、中空構造を有する微細な針状体を直接作製せず、第1の針状体基材に最終的に中空部の少なくとも一部を構成する溝を形成し、その後溝を含む第1の針状体基材の表面を被覆部材で覆う。このような工程によって、中空構造を有する針状体を製造する。したがって、実施形態に係る中空針状体の製造方法においては最初に表面に溝を有する第1の針状体基材を作製する。   The method for producing a hollow needle-like body according to the embodiment does not directly produce a fine needle-like body having a hollow structure, and the groove that finally constitutes at least a part of the hollow portion in the first needle-like body base material Then, the surface of the first acicular body substrate including the groove is covered with a covering member. By such a process, a needle-like body having a hollow structure is manufactured. Therefore, in the manufacturing method of the hollow needlelike object concerning an embodiment, the 1st needlelike object base material which has a slot on the surface first is produced.

表面に溝を有する第1の針状体基材は、公知の微細加工技術を用いて作製することができる。微細加工技術は、例えばリソグラフィ法、ウェットエッチング法、ドライエッチング法、サンドブラスト法、レーザー加工法、または精密機械加工法などを適宜組み合わせて用いることができる。   The 1st acicular body base material which has a groove | channel on the surface can be produced using a well-known fine processing technique. As the fine processing technique, for example, a lithography method, a wet etching method, a dry etching method, a sand blasting method, a laser processing method, or a precision machining method can be used in appropriate combination.

針状体は、微細加工技術によって所望の針状体構造を凹凸反転した形状の金型を作製すること、転写成形法により金型の形状を凹凸反転こと、により製造してもよい。金型は、その耐熱性、機械的強度および形状追従性を有すれば、特に材質の制約はない。金型の材質は、例えば金属、シリコン、ガラス、樹脂、セラミックスなどを用いることができる。転写成形材料は、ポリマー材料が好適である。ポリマー材料の金型への充填方法は、用いる成形材料に応じて公知の転写成形方法を適宜、用いることができる。転写成形法は、例えば射出成形法、押し出し成形法、インプリント法、キャスティング法などを採用することができる。   The needle-shaped body may be manufactured by producing a mold having a shape in which a desired needle-shaped body structure is inverted by a microfabrication technique, and by reversing the shape of the mold by a transfer molding method. The mold is not particularly limited as long as it has heat resistance, mechanical strength, and shape followability. As the material of the mold, for example, metal, silicon, glass, resin, ceramics, or the like can be used. The transfer molding material is preferably a polymer material. As a method of filling the polymer material into the mold, a known transfer molding method can be appropriately used depending on the molding material to be used. As the transfer molding method, for example, an injection molding method, an extrusion molding method, an imprint method, a casting method, or the like can be employed.

針状体の形状は、用途に応じて適宜設計し、選択することができる。針状体の形状は、例えば円錐や多角錐などの錐体形状、円錐台や多角錐台などの錐台形状、円柱や多角柱などの柱形状、柱形状の先端を斜めに切り落とした形状、またはこれらの形状を組み合わせた形状等を挙げることができる。   The shape of the needle-like body can be appropriately designed and selected according to the application. The shape of the needle-like body is, for example, a cone shape such as a cone or a polygonal pyramid, a truncated cone shape such as a truncated cone or a polygonal frustum, a column shape such as a cylinder or a polygonal column, a shape obtained by obliquely cutting off the tip of the column shape, Or the shape etc. which combined these shapes can be mentioned.

実施形態に係る中空針状体の製造において、第1の針状体基材表面の溝を覆うことが必須である。このため、溝が形成される第1の針状体基材の形状は少なくとも溝を形成する面が平坦であることが好ましい。具体的には、図1の(a)に示す円錐、図1の(b)に示す三角錐、図1の(c)に示す三角錐台、図1の(d)に示す直方体と三角錐の組み合わせ、図1の(e)に示すサイズの異なる三角錐の組み合わせ,の構造物をその中心を含む面で切断した形状が挙げられる。   In the manufacture of the hollow needle-like body according to the embodiment, it is essential to cover the groove on the surface of the first needle-like body substrate. For this reason, it is preferable that the shape of the 1st acicular body base material in which a groove | channel is formed at least the surface which forms a groove | channel is flat. Specifically, the cone shown in FIG. 1A, the triangular pyramid shown in FIG. 1B, the triangular frustum shown in FIG. 1C, the rectangular parallelepiped and the triangular pyramid shown in FIG. 1 or a combination of triangular pyramids having different sizes shown in FIG. 1E, a shape obtained by cutting a structure including a center thereof.

なお、図1において、第1の針状体基材は針状体部1aがその基底部において平板状の基板部2aに接続、保持された形態を有する。しかしながら、実施形態に係る中空針状体の製造はこれに限られるものではない。例えば、基板部を用いなくても、また基板部により保持されない場合であっても、また基板部は必ずしも平板形状でなくても、よい。   In FIG. 1, the first acicular body base material has a form in which the acicular body portion 1a is connected to and held by the flat substrate portion 2a at the base portion. However, the manufacture of the hollow needle-like body according to the embodiment is not limited to this. For example, even if the substrate portion is not used or is not held by the substrate portion, the substrate portion does not necessarily have a flat plate shape.

針状体の長さは、針状体の使用目的によって適宜選択することができる。皮膚内への生理活性物質の注入および皮膚内からの生体試料の取り出しの目的の場合には、針の長さは20〜2000μmにすることが好ましい。   The length of the needle-like body can be appropriately selected depending on the purpose of use of the needle-like body. For the purpose of injecting a physiologically active substance into the skin and taking out a biological sample from the skin, the needle length is preferably 20 to 2000 μm.

第1の針状体基材に形成する溝は、針状体の形状、寸法を逸脱しない範囲で、適宜設計できる。溝の形成方法は、特に制限はなく、所望の溝を形成可能な方法を適宜選択することができる。溝の形成方法は、例えばリソグラフィ法、ウェットエッチング法、ドライエッチング法、サンドブラスト法、レーザー加工法、精密機械加工法などを適宜組み合わせた方法を用いることができる。   The groove formed in the first acicular body base material can be appropriately designed within a range not departing from the shape and dimensions of the acicular body. The method for forming the groove is not particularly limited, and a method capable of forming a desired groove can be appropriately selected. As a method for forming the groove, for example, a method in which a lithography method, a wet etching method, a dry etching method, a sand blasting method, a laser processing method, a precision machining method, and the like are appropriately combined can be used.

第1の針状体基材への溝の形成は、微細加工技術によって所望の溝構造を凹凸反転した形状の金型を作製し、この金型を用いて転写成形法により溝を形成してもよい。金型は、その使用に耐え得る耐熱性、機械的強度および形状追従性を有すれば、特に材質の制約はない。金型の材質は、例えば金属、シリコン、ガラス、樹脂、セラミックスなどが挙げられる。転写成形法により成形される針状体の材料は、ポリマー材料が好適である。ポリマー材料の金型への充填方法は、用いる材料に応じて公知の転写成形方法を適宜選択すればよい。転写成形法は、例えば射出成形法、押し出し成形法、インプリント法、キャスティング法などを挙げることができる。   Grooves are formed on the first needle-shaped substrate by producing a mold having a shape in which a desired groove structure is inverted by a microfabrication technique, and forming a groove by a transfer molding method using this mold. Also good. The mold is not particularly limited as long as it has heat resistance, mechanical strength, and shape followability that can withstand its use. Examples of the material of the mold include metal, silicon, glass, resin, and ceramics. The material of the needle-shaped body formed by the transfer molding method is preferably a polymer material. As a method of filling the polymer material into the mold, a known transfer molding method may be appropriately selected according to the material to be used. Examples of the transfer molding method include an injection molding method, an extrusion molding method, an imprint method, and a casting method.

特に、第1の針状体基材の金型および溝の金型を準備し、これら2つの金型を位置合せし、ポリマーを充填して成形する方法を選択することによって、第1の針状体基材と溝とを一括成形できるため、針状体の生産性を向上できる。この方法により成形する場合には、射出成形法が特に好適である。   In particular, the first needle is obtained by preparing a first needle substrate mold and a groove mold, aligning the two molds, and filling and molding the polymer. Since the cylindrical base material and the groove can be collectively formed, the productivity of the needle-shaped body can be improved. When molding by this method, the injection molding method is particularly suitable.

このような2つの金型を用いる方法において、溝の金型のパターンを適宜設計することによって種々の溝の形態を第1の針状体基材に付与することが可能である。例えば、針状体基材の先端部から基板裏面に亘って直線状に溝を形成することによって、基板裏面から第1の針状体基材の先端に亘って直線状に流路を形成することができる。溝の金型を基板の裏面まで到達させなければ、第1の針状体基材の先端を通る未貫通の溝を形成することができる。   In such a method using two molds, various groove forms can be imparted to the first needle substrate by appropriately designing the groove mold pattern. For example, by forming a groove linearly from the tip of the needle-like body base to the back of the substrate, a flow path is formed linearly from the back of the substrate to the tip of the first needle-like base. be able to. If the groove mold does not reach the back surface of the substrate, an unpenetrated groove that passes through the tip of the first needle-shaped substrate can be formed.

実施形態に係る中空針状体の製造方法によると、針状体の中空構造となる部分を平面的な溝加工により形成することができる。このため、実施形態の方法は三次元加工で針状体の中空部を形成する場合、実現が困難な複雑な流路構造も容易に形成することが可能になる。例えば、流路へのテーパー形状の付与、流路の湾曲、L型接続、T型接続、などを容易に達成できる。   According to the method for manufacturing a hollow needle-like body according to the embodiment, a portion of the needle-like body having a hollow structure can be formed by planar groove processing. For this reason, when the method of the embodiment forms the hollow portion of the needle-like body by three-dimensional processing, it becomes possible to easily form a complicated flow channel structure that is difficult to realize. For example, it is possible to easily achieve the provision of a tapered shape to the flow path, the curvature of the flow path, the L-type connection, the T-type connection, and the like.

具体的には、図2の(a)に示す基板部2aの裏面から針状体部1aの先端(切除されている)までの溝3を容易に形成できる。また、図2の(b)に示す基板部2aの裏面から針状体部1aの中腹部までは直線的な溝形状とし、そこから横方向へ流路を曲げて接合針状体部1の中腹部に流路出口を設けた溝3も容易に形成できる。さらに前記図2の(b)に示す構造において、図2の(c)に示すように針状体部1aに設けた溝をさらに基板部2aの横方向に延びるように設けた溝3も容易に形成することができる。図2(c)に示すような分岐した溝構造にすることにより、流路出口(後述する開口部)から2種類の液体を輸送することが容易になる。   Specifically, the groove 3 from the back surface of the substrate portion 2a shown in FIG. 2A to the tip (cut out) of the needle-like body portion 1a can be easily formed. Further, a straight groove shape is formed from the back surface of the substrate part 2a shown in FIG. 2B to the middle part of the needle-like body part 1a, and the flow path is bent laterally from there to form the joint needle-like body part 1. The groove 3 provided with the channel outlet in the middle abdomen can be easily formed. Further, in the structure shown in FIG. 2B, the groove 3 provided so that the groove provided in the needle-like body portion 1a further extends in the lateral direction of the substrate portion 2a as shown in FIG. Can be formed. By making the branched groove structure as shown in FIG. 2 (c), it becomes easy to transport two types of liquids from the flow path outlet (opening described later).

金型を用いた転写成形法によって第1の針状体基材を成形する場合のポリマー材料は、特に制限はなく、公知のポリマー材料を適宜、使用することができる。ポリマー材料は、例えばポリエチレン、ポリプロピレン、ポリスチレン、ポリカーボネートなどが好適である。特に、針状体を生体に対して適用する場合には生分解性のポリマーを用いることが好ましい。生分解性のポリマーは、例えばポリε−カプロラクトン、ポリグリコール酸、およびこれらのポリマー材料のモノマーと乳酸のような他のモノマーとの共重合体などが好適である。   There is no particular limitation on the polymer material in the case of forming the first acicular body substrate by a transfer molding method using a mold, and a known polymer material can be appropriately used. As the polymer material, for example, polyethylene, polypropylene, polystyrene, polycarbonate and the like are suitable. In particular, when the acicular body is applied to a living body, it is preferable to use a biodegradable polymer. Suitable biodegradable polymers are, for example, polyε-caprolactone, polyglycolic acid, and copolymers of these polymer material monomers with other monomers such as lactic acid.

<第1の実施形態>
第1の実施形態に係る中空針状体の製造方法は、前述した第1の針状体基材の溝を含む面を被覆部材である第2の針状体基材で覆い、それによって内部に中空構造を有する針状体を製造する。
<First Embodiment>
The manufacturing method of the hollow needlelike object concerning a 1st embodiment covers the surface containing the slot of the 1st acicular object base mentioned above with the 2nd acicular object base material which is a covering member, and thereby it is an inside. A needle-like body having a hollow structure is manufactured.

第2の針状体基材の材質や形状には特に制限はない。針状体を生体に対して適用する場合には、生分解性のポリマーを用いることが好ましい。   There is no restriction | limiting in particular in the material and shape of a 2nd acicular body base material. When applying the needle-shaped body to a living body, it is preferable to use a biodegradable polymer.

次に、第1の針状体基材の溝を含む面を第2の針状体基材で覆って中空針状体を製造する工程を図3の(A)〜(C)を参照して説明する。   Next, a process of manufacturing a hollow needle-like body by covering the surface including the groove of the first needle-like body base material with the second needle-like body base material will be described with reference to FIGS. I will explain.

まず、図3の(A)に示すように針状体部1aと基板部2aとから構成され、針状体部1aから基板部2aにかけて溝3が形成された第1の針状体基材11を作製する。針状体部1aの形状は適宜設計され得る。ここでは、針状体部1aは先端が切除された正四角錐を底面の対角線と錐の中心軸(または錐の仮想頂点)を含む面で分割した形状を有する。   First, as shown in FIG. 3 (A), a first needle-like body base material comprising a needle-like body portion 1a and a substrate portion 2a and having grooves 3 formed from the needle-like body portion 1a to the substrate portion 2a. 11 is produced. The shape of the needle-like body portion 1a can be designed as appropriate. Here, the needle-like body portion 1a has a shape obtained by dividing a regular quadrangular pyramid whose tip is excised by a plane including the diagonal of the bottom surface and the central axis of the cone (or the virtual apex of the cone).

第1の針状体基材11の作製にあたっては、公知の精密加工技術または微細加工技術を適宜、用いることができる。例えば、精密加工技術を用いて所望する針状体部1aおよび基板部2aの形状を凹凸反転した針状体金型と、溝3の形状を凹凸反転した溝金型とを準備する。つづいて、針状体金型と溝金型を対向して位置合せした上で、ポリマーを射出充填することによって、溝3が形成されたポリマー製の第1の針状体基材11を得る。   In producing the first acicular body substrate 11, a known precision processing technique or fine processing technique can be used as appropriate. For example, a needle-shaped body mold in which the shapes of the desired needle-shaped body portion 1a and the substrate portion 2a are reversed using a precision machining technique and a groove mold in which the shape of the groove 3 is reversed are prepared. Subsequently, after the needle-shaped body mold and the groove mold are aligned to face each other, the polymer is injected and filled to obtain the first needle-shaped body base 11 made of polymer in which the grooves 3 are formed. .

また、針状体金型上に熱可塑性ポリマー材料を配置し、ポリマー材料を融点以上に加熱して溶融させた後、針状体金型に溝金型を位置合せし、プレス成形することによっても溝3が形成された第1の針状体基材11を得ることができる。   Also, by disposing a thermoplastic polymer material on the needle-shaped body mold, heating the polymer material above the melting point and melting it, aligning the groove mold to the needle-shaped body mold, and press molding. Also, the first acicular body substrate 11 in which the grooves 3 are formed can be obtained.

第2の針状体基材12を作製する。ここでは、第2の針状体基材12を、溝のない被覆部材として用いる場合について説明する。溝金型の代わりに溝形成用パターンを有さない金型を用い、前記第1の針状体基材の作製と同様な方法により、針状体部1bと基板部2bとから構成される第2の針状体基材12を得ることができる。なお、針状体部1bは第1の針状体基材11の針状体部1aと異なり、溝は設けられていない。   The 2nd acicular body base material 12 is produced. Here, the case where the 2nd acicular body base material 12 is used as a coating | coated member without a groove | channel is demonstrated. Instead of the groove mold, a mold having no groove forming pattern is used, and the needle-shaped body portion 1b and the substrate portion 2b are formed by the same method as the production of the first needle-shaped body base material. The 2nd acicular body base material 12 can be obtained. Unlike the needle-like body portion 1a of the first needle-like body substrate 11, the needle-like body portion 1b is not provided with a groove.

次いで、図3の(B)に示すように溝3が形成された第1の針状体基材11と溝が形成されていない第2の針状体基材12とを針状体部1aおよび針状体部1bが対向して位置合せし、接合する。図中、符号24は接合面を示す。接合により、図3の(C)に示すように内部に中空構造部21が形成された接合針状体部1と接合基板部2とからなる針状体13が得られる。なお、中空構造部21は図3の(B)に示すように接合針状体部1の中腹部に開口部22および接合基板部2の裏面にもう一方の開口部23をそれぞれ有する。   Next, as shown in FIG. 3B, the first needle-like body base material 11 in which the groove 3 is formed and the second needle-like body base material 12 in which the groove is not formed are connected to the needle-like body portion 1a. The needle-like body portion 1b is aligned and joined. In the figure, reference numeral 24 denotes a joint surface. By joining, as shown in FIG. 3C, a needle-like body 13 composed of a joined needle-like body portion 1 having a hollow structure portion 21 formed therein and a joining substrate portion 2 is obtained. As shown in FIG. 3B, the hollow structure portion 21 has an opening portion 22 in the middle part of the bonded needle-like body portion 1 and the other opening portion 23 on the back surface of the bonded substrate portion 2.

前述した第1の針状体基材11の溝3の形態を変更することによって、中空構造部21を多様に設計することが可能となる。例えば、接合針状体部1の開口部の位置を変える、開口部を複数設ける、中空部を未貫通とする、中空部をテーパー形状とする、ことができる。   By changing the shape of the groove 3 of the first acicular body base 11 described above, the hollow structure portion 21 can be designed in various ways. For example, the position of the opening part of the joining needle-like body part 1 can be changed, a plurality of openings can be provided, the hollow part can be non-penetrated, and the hollow part can be tapered.

ここでは、第2の針状体基材12に溝が形成されていない場合を示したが、第2の針状体基材12にも溝を形成してもよい。接合される第1の針状体基材11および第2の針状体基材12の両方に溝を設けることによって、より複雑な中空部構造部を形成することが可能になる。このため、第2の針状体基材12への溝形成の有無は用途によって選択することが好ましい。   Here, although the case where the groove | channel was not formed in the 2nd acicular body base material 12 was shown, you may form a groove | channel also in the 2nd acicular body base material 12. FIG. By providing grooves in both the first acicular body base material 11 and the second acicular body base material 12 to be joined, it becomes possible to form a more complicated hollow portion structure portion. For this reason, it is preferable to select the presence or absence of the groove formation in the 2nd acicular body base material 12 according to a use.

第1および第2の針状体基材の接合方法は、特に制限はなく、針状体基材の材質または形状、寸法などに考慮して公知の接合方法を適宜、用いることができる。接合方法は、例えばレーザー溶着法、熱溶着法、振動溶着法、超音波溶着法、接着剤接着法などを用いることができる。この接合方法において、接合強度を向上させるために、接合に先立って接合面に処理を施してもよい。   The joining method of the first and second acicular body base materials is not particularly limited, and a known joining method can be appropriately used in consideration of the material, shape, dimensions, etc. of the acicular body base material. As a bonding method, for example, a laser welding method, a thermal welding method, a vibration welding method, an ultrasonic welding method, an adhesive bonding method, or the like can be used. In this bonding method, in order to improve the bonding strength, the bonding surface may be processed prior to bonding.

中空針状体の製造方法において、中空構造部21の表面濡れ性等を制御することが場合によって好ましい。しかしながら、一般的に微細かつ細長い孔の内部の表面改質を有効に実施することは困難な場合がある。実施形態に係る中空針状体の製造方法は、中空構造部21を形成する前の段階で溝3に表面改質を実施することが可能であるため、中空構造部の内部においても十分な表面改質効果が期待できる。表面改質を施す場合、少なくとも溝3の表面に実施する他に、第2の針状体基材12の表面のうち、接合後に中空構造部21の内面を構成する領域にも表面改質を施すことが好ましい。表面改質の方法は特に限定されず、針状体基材の材質や所望する表面特性に応じて公知の方法を適宜、用いることができる。表面改質は、例えばプラズマ処理、エッチング処理、成膜処理などを利用することができる。   In the method for manufacturing a hollow needle-like body, it is preferable in some cases to control the surface wettability of the hollow structure portion 21. However, in general, it may be difficult to effectively carry out surface modification inside the fine and elongated holes. In the method for manufacturing a hollow needle-like body according to the embodiment, since the surface modification can be performed on the groove 3 at a stage before the hollow structure portion 21 is formed, a sufficient surface is provided even inside the hollow structure portion. A reforming effect can be expected. When surface modification is performed, in addition to the surface modification of at least the surface of the groove 3, the surface modification is also performed on the region of the surface of the second acicular body 12 that forms the inner surface of the hollow structure portion 21 after joining. It is preferable to apply. The surface modification method is not particularly limited, and a known method can be appropriately used according to the material of the needle-shaped body substrate and the desired surface characteristics. For the surface modification, for example, plasma treatment, etching treatment, film formation treatment, or the like can be used.

以上の工程により、図3の(C)に示すように、中空の針状体13が得られる。この中空の針状体13において、接合針状体部1は正四角錐であり、接合針状体部1の側面の開口部22と接合基板部2の裏面の開口部(図示せず)を連結する中空構造(図示せず)を内部に有する。   Through the above steps, a hollow needle-like body 13 is obtained as shown in FIG. In this hollow needle-like body 13, the joining needle-like body portion 1 is a regular quadrangular pyramid, and connects the opening 22 on the side surface of the joining needle-like body portion 1 and the opening on the back surface of the joining substrate portion 2 (not shown). A hollow structure (not shown) is provided inside.

図3の(C)に示す針状体部1の側面に開口部を備える中空の針状体は、針状体部1の先端に開口部を備える中空の針状体と比較して、針状体部の先端を先鋭化することができるこのため、皮膚への穿刺性に優れた針状体を得ることができる。   The hollow needle-like body having an opening on the side surface of the needle-like body portion 1 shown in FIG. 3C is compared with the hollow needle-like body having an opening at the tip of the needle-like body portion 1. Since the tip of the body portion can be sharpened, a needle-like body having excellent puncture ability to the skin can be obtained.

<第2の実施形態>
第2の実施形態に係る中空針状体の製造方法は、前述した第1の針状体基材の溝を含む面を被覆部材である第2の針状体基材で覆い、それによって内部に中空構造を有する針状体を製造する。この製造工程を図4の(A),(B)を参照して説明する。第2の実施形態は、前記図3の(A)〜(C)を用いて説明した第1の実施形態における針状体基材と溝の形状を一部変更したものである。
<Second Embodiment>
In the method for manufacturing a hollow needle-like body according to the second embodiment, the surface including the groove of the first needle-like body base material described above is covered with the second needle-like body base material that is a covering member, and thereby the inside. A needle-like body having a hollow structure is manufactured. This manufacturing process will be described with reference to FIGS. In the second embodiment, the shape of the acicular body substrate and the groove in the first embodiment described with reference to FIGS. 3A to 3C is partially changed.

図4の(A)に示すように第1の針状体基材11の溝3は、錐台形状の針状体部1aの頂点から基板部2aの裏面にかけて直線状に形成されている。対向する第2の針状体基材12の針状体部1bも角錐台形であるが、第1の針状体基材11の針状体部1aよりも短くなっている。両者を接合すると、図4の(B)に示す形態の接合針状体部1および接合基板部2からなる針状体13が得られる。図中、参照符号24は、接合面を示す。   As shown in FIG. 4A, the groove 3 of the first acicular body base 11 is formed linearly from the apex of the frustum-shaped acicular body portion 1a to the back surface of the substrate portion 2a. The opposing needle-like body portion 1b of the second needle-like body base material 12 also has a truncated pyramid shape, but is shorter than the needle-like body portion 1a of the first needle-like body base material 11. When both are joined, a needle-like body 13 composed of the joint needle-like body portion 1 and the joint substrate portion 2 in the form shown in FIG. 4B is obtained. In the figure, reference numeral 24 indicates a joint surface.

第2の実施形態において、中空構造部21は接合針状体部1の中腹部に開口部22および接合基板部2の裏面にもう一方の開口部23をそれぞれ有する。   In the second embodiment, the hollow structure portion 21 has an opening portion 22 in the middle part of the bonded needle-like body portion 1 and the other opening portion 23 on the back surface of the bonded substrate portion 2.

第2の実施形態において、図4に示すように溝3を有する第1の針状体基材11の針状部1aと第2の針状体基材12の針状体部1bは長さが異なり、接合後の針状体13において接合針状体部1が段差を備え、当該段差部分に開口部22が形成される。第2の実施形態における針状体は、図4に示すような溝を有する第1の針状体基材の針状体部長さが第2の針状体基材のそれよりも長い構造に限定されない。例えば、溝を有する第1の針状体基材の針状体部長さが第2の針状体基材のそれよりも短い構造とすることもできる。   In the second embodiment, as shown in FIG. 4, the needle-like part 1 a of the first needle-like body base material 11 having the groove 3 and the needle-like body part 1 b of the second needle-like body base material 12 are long. However, the joined needle-like body portion 1 has a step in the joined needle-like body 13, and an opening 22 is formed in the step portion. The needle-like body in the second embodiment has a structure in which the length of the needle-like body portion of the first needle-like body base material having a groove as shown in FIG. 4 is longer than that of the second needle-like body base material. It is not limited. For example, the first acicular body base having a groove may have a structure in which the length of the acicular body portion is shorter than that of the second acicular body base.

第2の実施形態に係る針状体は、先端が接合面を含まないため成形のみで精度の高い針状体部先端が形成できる。このため、皮膚への穿刺性に優れるという利点を有する。さらに、段差部分に形成される開口部22の先に第1の針状体基材もしくは第2の針状体基材を備えることにより、当該針状体を皮膚に穿刺した際に開口部近傍に段差による空間が形成される。その結果、皮膚内への液体注入性に優れた針状体を得ることができる。   Since the needle-like body according to the second embodiment does not include a joint surface, the needle-like body tip can be formed with high accuracy only by molding. For this reason, it has the advantage that it is excellent in the puncture property to skin. Further, by providing the first needle-like body substrate or the second needle-like body substrate at the tip of the opening 22 formed in the stepped portion, when the needle-like body is punctured into the skin, the vicinity of the opening A space is formed by steps. As a result, it is possible to obtain a needle-like body having excellent liquid injection properties into the skin.

<第3の実施形態>
図5は、第3の実施形態に係る中空針状体の製造方法を示す斜視図である。第1および第2の針状体基材11,12を接合する際、接合位置を合せるために嵌め合せ構造を基板部に付与している。すなわち、第1の針状体基材11の基板部2aの上部に嵌め合せ凹部31を設け、凹部31と対向する第2の針状体基材12の基板部2bに嵌め合せ凸部32を設ける。第1の針状体基材11と第2の針状体基材12を接合する際に、それぞれの基板部2a,2bに設けた凹部31および突部32を嵌め合せることによって、接合位置を正確に設計できる。嵌め合せ構造の形状や寸法は特に限定されるものではなく、適宜設計すればよい。
<Third Embodiment>
FIG. 5 is a perspective view showing a method for manufacturing a hollow needle-like body according to the third embodiment. When the first and second acicular body base materials 11 and 12 are joined, a fitting structure is given to the substrate portion in order to match the joining positions. That is, the fitting concave portion 31 is provided on the upper portion of the substrate portion 2 a of the first needle-shaped body base material 11, and the fitting convex portion 32 is formed on the substrate portion 2 b of the second needle-shaped body base material 12 facing the concave portion 31. Provide. When the first acicular body base 11 and the second acicular body base 12 are joined, the joining position is determined by fitting the concave portions 31 and the protrusions 32 provided in the respective substrate portions 2a and 2b. Design accurately. The shape and size of the fitting structure are not particularly limited, and may be appropriately designed.

<第4の実施形態>
図6の(A)〜(C)は、第4の実施形態に係る中空針状体の製造工程を示す斜視図である。図6において、第1の針状体基材11に形成された溝3を覆う被覆部材は、シート14である。
<Fourth Embodiment>
FIGS. 6A to 6C are perspective views showing a manufacturing process of the hollow needle-like body according to the fourth embodiment. In FIG. 6, the covering member that covers the groove 3 formed in the first acicular body substrate 11 is a sheet 14.

まず、図6の(A)に示すように溝3を有する第1の針状体基材11とシート14とを用意する。図6の(B)に示すように第1の針状体基材11の溝3が形成された面の全面をシート14で覆い、接合する。つづいて、シート14のうち、第1の針状体基材11を覆っていない余剰部分を除去して、図6の(C)に示す中空構造を有する中空針状体13を製造する。   First, as shown in FIG. 6A, a first acicular body substrate 11 having a groove 3 and a sheet 14 are prepared. As shown in FIG. 6B, the entire surface of the first acicular body substrate 11 where the grooves 3 are formed is covered with a sheet 14 and bonded. Subsequently, a surplus portion of the sheet 14 that does not cover the first acicular body substrate 11 is removed to produce a hollow acicular body 13 having a hollow structure shown in FIG.

シート14の余剰部分の除去は、シート14、針状体部1a、および基板部2aの形状、寸法、材質などを考慮した上、公知の方法を用いて、適宜行うことができる。この除去は、例えばレーザー法、材質のエッチング選択性を利用したエッチング法、サンドブラスト法などが挙げられる。   The excessive portion of the sheet 14 can be removed as appropriate using a known method in consideration of the shape, dimensions, material, and the like of the sheet 14, the needle-like body portion 1a, and the substrate portion 2a. Examples of the removal include a laser method, an etching method using etching selectivity of a material, and a sand blast method.

第4の実施形態に係る中空針状体は、第2の針状体基材としてシート状部材を用いることにより、第1の針状体基材と第2の針状体基材の接合時に精密な位置合わせを行なう必要がない。このため、製造工程を簡便化できる。   The hollow acicular body according to the fourth embodiment uses a sheet-like member as the second acicular body base material, so that the first acicular body base material and the second acicular body base material are joined. There is no need for precise alignment. For this reason, a manufacturing process can be simplified.

<第5の実施形態>
図7の(A),(B)は、第5の実施形態に係る中空針状体の製造方法を示す斜視図である。前記第1〜第4の実施形態では、1つの針状体を備える例について説明したが、図7に示すように一列に配列された針状体を一括して作製することが可能である。
<Fifth Embodiment>
FIGS. 7A and 7B are perspective views showing a method for manufacturing a hollow needle-like body according to the fifth embodiment. In the first to fourth embodiments, an example in which one needle-like body is provided has been described. However, needle-like bodies arranged in a line as shown in FIG. 7 can be manufactured in a lump.

金型を用いたポリマー材料の転写成形法を用いる場合は、針状体が一列に複数配列された金型を準備し、図7の(A)に示す成形品である第1の針状体基材11および第2の針状体基材12を作製する。第1の針状体基材11は、針状体部1aと基板部2aとから構成され、針状体部1aから基板部2aにかけて溝3が形成された構造体を一列に複数連ねた形状を有する。第2の針状体基材12は、針状体部1bと基板部2bとから構成され、溝のない針状体部1bの構造体を一列に複数連ねた形状を有する。つづいて、第1、第2の針状体基材11,12を接合することによって、図7の(B)に示す複数の中空針状体が1列に配置された針状体を製造することができる。   In the case of using a transfer molding method of a polymer material using a mold, a mold having a plurality of needle-like bodies arranged in a row is prepared, and the first needle-like body which is a molded product shown in FIG. The base material 11 and the second acicular body base material 12 are produced. The 1st acicular body base material 11 is comprised from the acicular body part 1a and the board | substrate part 2a, and the shape which connected the structure in which the groove | channel 3 was formed from the acicular body part 1a to the board | substrate part 2a in a row in multiple numbers. Have The 2nd acicular body base material 12 is comprised from the acicular body part 1b and the board | substrate part 2b, and has the shape which connected the structure of the acicular body part 1b without a groove | channel in one row. Subsequently, by joining the first and second needle-like body bases 11 and 12, a needle-like body in which a plurality of hollow needle-like bodies shown in FIG. be able to.

<第6の実施形態>
図8は、第6の実施形態に係る中空針状体を示す斜視図である。一枚の接合基板部2上に1本の接合針状体部1を備えた針状体13を縦横複数配置し、接合基板部2の端面同士を接合することにより、図8に示す複数の接合針状体部1がアレイ上に配置された針状体を得ることができる。また、複数の接合針状体部が1列に配列された針状体を行方向に複数配置し、基板部の端面同士を接合することによっても、図8と同様の構成の針状体を得ることができる。これらの場合、予め接合基板部2の内部に接合基板部2表面に並行に走る中空流路を設け、接合によって各々の流路を接続すれば、基板内部に流路のネットワークを有する中空針状体が得られる。
<Sixth Embodiment>
FIG. 8 is a perspective view showing a hollow needle-like body according to the sixth embodiment. A plurality of needle-like bodies 13 each having one joined needle-like body portion 1 are arranged on one joining substrate portion 2 and the end surfaces of the joining substrate portion 2 are joined to each other. A needle-like body in which the bonded needle-like body portions 1 are arranged on the array can be obtained. Also, by arranging a plurality of needle-like bodies in which a plurality of joined needle-like body portions are arranged in a row in the row direction and joining the end faces of the substrate portions, a needle-like body having the same configuration as in FIG. Can be obtained. In these cases, if hollow channels that run in parallel to the surface of the bonded substrate portion 2 are provided in the bonded substrate portion 2 in advance, and each flow channel is connected by bonding, a hollow needle shape having a network of flow channels inside the substrate The body is obtained.

また、流路には、各開口部毎に異なる2種類以上の液体を輸送することもできる。   Also, two or more types of liquids that are different for each opening can be transported to the channel.

前述した方法によって中空部の開口部の一方を針状体に、もう一方の開口部を基板部(例えば基板部裏面)に形成した中空構造部を貫通構造として有する針状体を得ることができる。このような針状体において、基板部の開口部に送液手段および吸引手段の少なくとも一方の手段を接続することによって、針状体を介した液体の輸送が簡便に実施可能となる。送液手段、吸引手段は、ポンプや注射器を挙げることができる。特に、送液/吸引手段としてマイクロポンプを用い、中空針状体の基板部に接合することによって、送液/吸引機能を有する中空針状体システムの小型化を実現できる。   By the above-described method, a needle-like body having a hollow structure portion in which one of the openings of the hollow portion is formed into a needle-like body and the other opening portion is formed on the substrate portion (for example, the back surface of the substrate portion) as a penetrating structure can be obtained. . In such a needle-like body, the liquid can be easily transported through the needle-like body by connecting at least one of the liquid feeding means and the suction means to the opening of the substrate portion. Examples of the liquid feeding means and the suction means include a pump and a syringe. In particular, a hollow pump-like body system having a liquid-feeding / suctioning function can be miniaturized by using a micro pump as the liquid feeding / suction means and joining the substrate to the hollow needle-like substrate.

<第7の実施形態>
第7の実施形態に係る中空針状体の製造方法は、前述した錐体の頂部を含む面ではなく、錐体の頂部を含まない面を第1の針状体基材と第2の針状体基材の接合面として用いている。換言すると、針状体部1aは先端が切除された正四角錐を底面の対角線と錐の中心軸(または錐の仮想頂点)を含まない面で分割した形状を有する。
<Seventh Embodiment>
The manufacturing method of the hollow needlelike object concerning a 7th embodiment is not the field which contains the top part of a cone mentioned above, but the surface which does not contain the top part of a cone, the 1st needlelike object substrate and the 2nd needle It is used as the joint surface of the solid substrate. In other words, the needle-like body portion 1a has a shape obtained by dividing a regular quadrangular pyramid whose tip is excised by a plane that does not include the diagonal of the bottom surface and the central axis of the cone (or the virtual apex of the cone).

第7の実施形態における、第1の針状体基材の溝を含む面を第2の針状体基材で覆って中空針状体を製造する工程を図9の(A)〜(C)を参照して説明する。   9A to 9C show the steps of manufacturing the hollow needle-like body by covering the surface including the groove of the first needle-like body base material with the second needle-like base material in the seventh embodiment. ) Will be described.

まず、図9の(A)に示すように針状体部1aと基板部2aとから構成され、針状体部1aから基板部2aにかけて溝3が形成された第1の針状体基材11を作製する。針状体部1aの形状は適宜設計され得る。ここでは、針状体部1aは先端が切除された正四角錐を底面の対角線と錐の中心軸(または錐の仮想頂点)を含まない面で分割した形状を有する。   First, as shown in FIG. 9 (A), a first acicular body base material which is composed of an acicular body portion 1a and a substrate portion 2a and in which a groove 3 is formed from the acicular body portion 1a to the substrate portion 2a. 11 is produced. The shape of the needle-like body portion 1a can be designed as appropriate. Here, the needle-like body portion 1a has a shape obtained by dividing a regular quadrangular pyramid whose tip is excised by a plane that does not include the diagonal of the bottom surface and the central axis of the cone (or the virtual apex of the cone).

次いで、図9の(B)に示すように溝3が形成された第1の針状体基材11と溝が形成されていない第2の針状体基材12とを針状体部1aおよび針状体部1bが対向して位置合せし、接合する。図中、符号24は接合面を示す。接合により、図9の(C)に示すように内部に中空構造部21が形成された接合針状体部1と接合基板部2とからなる針状体13が得られる。   Next, as shown in FIG. 9B, the first needle-like body base material 11 in which the groove 3 is formed and the second needle-like body base material 12 in which the groove is not formed are connected to the needle-like body portion 1a. The needle-like body portion 1b is aligned and joined. In the figure, reference numeral 24 denotes a joint surface. By joining, as shown in FIG. 9C, a needle-like body 13 composed of a joined needle-like body portion 1 having a hollow structure portion 21 formed therein and a joining substrate portion 2 is obtained.

また、図10は、図9(A)に示す第1の針状体基材11の溝3を含む面をシート14である第2の針状体基材で覆うことによって製造される内部に中空構造を有する針状体を示す。   Moreover, FIG. 10 shows the inside manufactured by covering the surface including the groove 3 of the first acicular body base 11 shown in FIG. 9A with the second acicular body base that is the sheet 14. The acicular body which has a hollow structure is shown.

第7の実施形態による針状体は、先端が接合面を含まないため、成形のみで精度の高い針状体部先端が形成でき、皮膚への穿刺性が優れるという利点を有する。   Since the needle-like body according to the seventh embodiment does not include a joint surface, the needle-like body tip can be formed with high accuracy only by molding, and has an advantage that the puncture property to the skin is excellent.

なお、本発明の針状体の製造方法は上記実施形態に限定されず、各工程において類推することのできる他の公知の工程に置き換えた方法をも含む。   In addition, the manufacturing method of the acicular body of this invention is not limited to the said embodiment, The method replaced with the other well-known process which can be estimated in each process is also included.

以上説明したように実施形態によれば、内部に中空部を有する中空針状体を製造する方法であって、中空針状体を分割した、表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材と被覆部材とを作製し、前記第1の針状体基材の溝を含む面を前記被覆部材で覆うことによって、中空針状体を簡便かつ量産的に製造することが可能な方法を提供できる。   As described above, according to the embodiment, there is provided a method for manufacturing a hollow needle-like body having a hollow portion therein, the groove forming the at least part of the hollow portion on the surface, which is obtained by dividing the hollow needle-like body. A hollow needle-like body can be easily and mass-produced by preparing a first needle-like body base material and a covering member having a surface and covering the surface including the groove of the first needle-like body base material with the covering member. It is possible to provide a method that can be manufactured.

以下、本発明の実施例を前述した図面を参照して説明する。   Embodiments of the present invention will be described below with reference to the drawings described above.

(実施例1)
まず、精密機械加工によって、高さ1000μm、底面の1辺が280μmの正四角錐を底面の対角線と錐の頂点を含む面で分割して得た三角錐形状を凹凸反転した金型を作製した。また、精密機械加工によって、幅60μm、高さ60μmの突起構造を有する溝形成用金型を作製した。溝形成用金型の突起構造は、最終的に得られる中空針状体基板において、基板部裏面と、針状体中腹部(高さ約500μm)に開口部が位置し、針状体内部で屈曲するように設計した。
Example 1
First, a mold was produced by reversing a triangular pyramid shape obtained by dividing a regular quadrangular pyramid having a height of 1000 μm and a bottom side of 280 μm by a plane including the diagonal line of the bottom surface and the apex of the cone by precision machining. Further, a groove forming mold having a protrusion structure with a width of 60 μm and a height of 60 μm was produced by precision machining. The protrusion structure of the groove forming mold is such that, in the finally obtained hollow needle substrate, openings are located on the back surface of the substrate portion and in the needle body abdomen (height of about 500 μm). Designed to bend.

次いで、成形材料であるポリプロピレンと前記金型および溝形成用金型を用い、射出成形法により針状体1aが基板部2aに保持された形態の、溝3を有する第1の針状体基材11を成形した。また、成形材料であるポリプロピレンと前記三角錐形状を凹凸反転した金型を用い、射出成形法により針状体1bが基板部2bに保持された形態の、溝のない第2の針状体基材12を成形した(図3の(A)図示)。なお、針状体基材12は、溝がないことを除いて針状体基材11と同様の形状であった。   Next, a first needle-like body base having a groove 3 in a form in which the needle-like body 1a is held by the substrate portion 2a by an injection molding method using polypropylene as a molding material, the above-described mold, and a groove-forming mold. Material 11 was molded. Also, a second needle-like body base without a groove in a form in which the needle-like body 1b is held on the substrate portion 2b by an injection molding method using polypropylene which is a molding material and a mold obtained by reversing the triangular pyramid shape. The material 12 was molded (shown in FIG. 3A). In addition, the acicular body base material 12 was the same shape as the acicular body base material 11 except that there was no groove.

次いで、第1の針状体基材11と第2の針状体基材12を光学顕微鏡で観察しながら位置を合わせて対向させ、図3の(B)に示すように接合した。これにより、図3の(C)に示す、内部に中空構造部21が形成された接合針状体部1と接合基板部2とからなる針状体13を得た。   Next, the first acicular body substrate 11 and the second acicular body substrate 12 were opposed to each other while being observed with an optical microscope, and joined as shown in FIG. As a result, a needle-like body 13 composed of a joint needle-like body portion 1 and a joint substrate portion 2 having a hollow structure portion 21 formed therein, as shown in FIG.

得られた針状体13の接合針状体部1は、高さ1000μm、底面の一辺の長さが280μmの正四角錐形状であった。また、接合針状体部1は針の高さが500μmの位置に縦横約60μmの正方形の開口部22を有し、かつ接合基板部2の裏面にも縦横約60μmの正方形の開口部(図示せず)を有していた。このような形態は、走査電子顕微鏡による観察で確認した。さらに、中空構造体の内部を走査電子顕微鏡で観察したところ、開口部付近は中空構造であることを確認できたが、内部の状況までは観察できなかった。   The joined needle-like body portion 1 of the obtained needle-like body 13 had a regular quadrangular pyramid shape with a height of 1000 μm and a length of one side of the bottom surface of 280 μm. In addition, the bonded needle-like body portion 1 has a square opening portion 22 having a height and width of about 60 μm at a position where the height of the needle is 500 μm, and a square opening portion having a height and width of about 60 μm on the back surface of the bonding substrate portion 2 (see FIG. Not shown). Such a form was confirmed by observation with a scanning electron microscope. Furthermore, when the inside of the hollow structure was observed with a scanning electron microscope, it was confirmed that the vicinity of the opening had a hollow structure, but the internal situation could not be observed.

次に、同様の方法により針状体13を合計9個作製し、各々を接合して図8に示す接合基板部2上に接合針状体部1が形成された針状体13を3行3列で配列された針状体アレイを得た。針状体アレイの基板の裏面をプラスチック製のシリンジ先端部に接触させ、針状体アレイの裏面に形成された開口部を塞がないように接着剤で接合した。   Next, a total of nine needle-like bodies 13 are produced by the same method, and three rows of needle-like bodies 13 in which the joined needle-like body portions 1 are formed on the joining substrate portion 2 shown in FIG. 8 are joined. A needle array arranged in three rows was obtained. The back surface of the needle-like array substrate was brought into contact with the tip of the plastic syringe, and the openings formed on the back surface of the needle-like body array were joined with an adhesive so as not to block.

シリンジ内に純水を充填し、接合針状体部1を実体顕微鏡で観察しながらプランジャに圧力を加えたところ、9本全ての接合針状体部1の中腹部から純水が射出されたことを確認した。このとき、接合基板部2やリシンジとの接続部からの漏れは確認されなかった。   When pure water was filled in the syringe and pressure was applied to the plunger while observing the joined needle-like body part 1 with a stereomicroscope, pure water was ejected from the mid-abdominal part of all nine joined needle-like body parts 1. It was confirmed. At this time, the leakage from the connection part with the joining board | substrate part 2 or a ricinji was not confirmed.

以上の結果から、作製した針状体アレイ内部の中空構造部が流路として機能していることを確認することができた。   From the above results, it was confirmed that the hollow structure portion inside the produced needle-like body array functions as a flow path.

(実施例2)
まず、実施例1と同様に、精密機械加工によって、高さ1500μm、底面の1辺が420μmの正四角錐を底面の対角線と錐の頂点を含む面で分割して得た三角錐形状を凹凸反転した金型を作製した。また、精密機械加工によって、幅60μm、高さ60μmの突起構造を有する溝形成用金型を作製した。溝形成用金型の突起構造は、最終的に得られる中空針状体基板において、基板部裏面と、針状体中腹部(高さ約500μm)に開口部が位置し、針状体内部で屈曲するように設計した。
(Example 2)
First, in the same manner as in Example 1, the triangular pyramid shape obtained by dividing a regular quadrangular pyramid with a height of 1500 μm and a bottom side of 420 μm by a plane including the diagonal line of the bottom and the apex of the cone by precision machining was reversed. A mold was prepared. Further, a groove forming mold having a protrusion structure with a width of 60 μm and a height of 60 μm was produced by precision machining. The protrusion structure of the groove forming mold is such that, in the finally obtained hollow needle substrate, openings are located on the back surface of the substrate portion and in the needle body abdomen (height of about 500 μm). Designed to bend.

次いで、成形材料であるポリプロピレンと前記金型および溝形成用金型を用い、射出成形法により針状体1aが基板部2aに保持された形態の、溝3を有する第1の針状体基材11を成形した。また、厚さ50μmのポリプロピレンからなるシートを用意した。(図6の(A)図示)。   Next, a first needle-like body base having a groove 3 in a form in which the needle-like body 1a is held by the substrate portion 2a by an injection molding method using polypropylene as a molding material, the above-described mold, and a groove-forming mold. Material 11 was molded. A sheet made of polypropylene having a thickness of 50 μm was prepared. (Shown in FIG. 6A).

次いで、第1の針状体基板とポリプロピレンシートを図6の(B)に示すように接合した。最後にレーザーにより第1の針状体基板と接合していない余剰のポリプロピレンシートを除去し、図6の(C)に示す、内部に中空構造部21が形成された接合針状体部1と接合基板部2とからなる針状体13を得た。   Next, the first needle substrate and the polypropylene sheet were joined as shown in FIG. Finally, the excess polypropylene sheet not bonded to the first acicular substrate is removed by a laser, and the bonded acicular body portion 1 having the hollow structure portion 21 formed therein is shown in FIG. The acicular body 13 composed of the bonded substrate portion 2 was obtained.

得られた針状体13の接合針状体部1は、高さ約1000μm、底面の一辺の長さが約280μmの正四角錐形状を2分割した三角錐形状であった。また、接合針状体部1は針の高さが約500μmの位置に縦横約60μmの正方形の開口部22を有し、かつ接合基板部2の裏面にも縦横約60μmの正方形の開口部(図示せず)を有していた。このような形態は、走査電子顕微鏡による観察で確認した。   The joined needle-like body portion 1 of the obtained needle-like body 13 had a triangular pyramid shape obtained by dividing a regular quadrangular pyramid shape having a height of about 1000 μm and a side length of about 280 μm into two. In addition, the bonded needle-like body portion 1 has a square opening portion 22 of about 60 μm in length and width at a position where the needle height is about 500 μm, and a square opening portion of about 60 μm in length and width on the back surface of the bonding substrate portion 2 ( (Not shown). Such a form was confirmed by observation with a scanning electron microscope.

次に、針状体アレイの基板の裏面をプラスチック製のシリンジ先端部に接触させ、針状体アレイの裏面に形成された開口部を塞がないように接着剤で接合した。シリンジ内に純水を充填し、接合針状体部1を実体顕微鏡で観察しながらプランジャに圧力を加えた。その結果、接合針状体部1の中腹部から純水が射出されたことを確認した。このとき、接合基板部2やリシンジとの接続部からの漏れは確認されなかった。   Next, the back surface of the needle-shaped array was brought into contact with the tip of the plastic syringe, and the openings formed on the back surface of the needle-shaped array were bonded with an adhesive so as not to be blocked. The syringe was filled with pure water, and pressure was applied to the plunger while observing the joined needle-like body 1 with a stereomicroscope. As a result, it was confirmed that pure water was injected from the middle part of the joined needle-like body 1. At this time, the leakage from the connection part with the joining board | substrate part 2 or a ricinji was not confirmed.

以上の結果から、作製した針状体アレイ内部の中空構造部が流路として機能していることを確認することができた。   From the above results, it was confirmed that the hollow structure portion inside the produced needle-like body array functions as a flow path.

(実施例3)
まず、実施例1と同様に、精密機械加工によって、高さ1000μm、底面の1辺が280μmの正四角錐を底面の対角線と錐の頂点を含む面で分割して得た三角錐形状を凹凸反転した金型を作製した。また、精密機械加工によって、幅60μm、高さ60μmの突起構造を有し、かつ基板部において凸形状を備える溝形成用金型を作製した。溝形成用金型の突起構造は、最終的に得られる中空針状体基板において、基板部裏面と、針状体中腹部(高さ約500μm)に開口部が位置し、針状体内部で屈曲するように設計した。
(Example 3)
First, in the same manner as in Example 1, the triangular pyramid shape obtained by dividing a regular quadrangular pyramid with a height of 1000 μm and a bottom side of 280 μm by a plane including the diagonal line of the bottom surface and the apex of the cone by precision machining is inverted. A mold was prepared. In addition, a groove forming mold having a protruding structure with a width of 60 μm and a height of 60 μm and having a convex shape in the substrate portion was produced by precision machining. The protrusion structure of the groove forming mold is such that, in the finally obtained hollow needle substrate, openings are located on the back surface of the substrate portion and in the needle body abdomen (height of about 500 μm). Designed to bend.

また、前記溝形成用金型の凸形状を反転した凹形状を基板部に備える第2の金型を作成した。   Moreover, the 2nd metal mold | die provided with the concave shape which reversed the convex shape of the said metal mold | die for groove | channel formation in a board | substrate part was created.

次いで、成形材料であるポリプロピレンと前記金型および溝形成用金型を用い、射出成形法により針状体1aが基板部2aに保持された形態の、溝3および凹部31を有する第1の針状体基材11を成形した。さらに、成形材料であるポリプロピレンと前記金型および第2の金型を用い、射出成形法により針状体1aが基板部2aに保持された形態の、凸部32を有する第2の針状体基材12を成形した(図5図示)。   Next, the first needle having the groove 3 and the recess 31 in the form in which the needle-like body 1a is held by the substrate part 2a by the injection molding method using polypropylene as the molding material, the above-described mold and the groove-forming mold. A shaped substrate 11 was formed. Further, a second needle-like body having a convex portion 32 in a form in which the needle-like body 1a is held on the substrate portion 2a by an injection molding method using polypropylene as a molding material, the above-described mold, and the second mold. The substrate 12 was molded (shown in FIG. 5).

次いで、第1の針状体基材11と第2の針状体基材12を光学顕微鏡で観察しながら位置を合わせて対向させ、接合した。これにより、内部に中空構造部21が形成された接合針状体部1と接合基板部2とからなる針状体13を得た。このとき、実施例1の第1の針状体基材11と第2の針状体基材12の接合工程と比較して、位置合わせの時間を短くすることができた。   Next, the first acicular body base material 11 and the second acicular body base material 12 were aligned and opposed to each other while being observed with an optical microscope. Thereby, the acicular body 13 which consists of the joining acicular body part 1 in which the hollow structure part 21 was formed, and the joining board | substrate part 2 was obtained. At this time, compared with the joining process of the 1st acicular body base material 11 of Example 1 and the 2nd acicular body base material 12, the time of alignment was able to be shortened.

得られた針状体は、(実施例1)と同様の針状体であることが走査電子顕微鏡による観察で確認された。また、針状体アレイの基板の裏面をプラスチック製のシリンジ先端部に接触させ、針状体アレイの裏面に形成された開口部を塞がないように接着剤で接合した。シリンジ内に純水を充填し、接合針状体部1を実体顕微鏡で観察しながらプランジャに圧力を加えた。その結果、接合針状体部1の中腹部から純水が射出されたことを確認した。このとき、接合基板部2やリシンジとの接続部からの漏れは確認されなかった。   It was confirmed by observation with a scanning electron microscope that the obtained needle-like body was a needle-like body similar to (Example 1). Further, the back surface of the needle-shaped array was brought into contact with the tip of the plastic syringe, and the openings formed on the back surface of the needle-shaped array were bonded with an adhesive so as not to be blocked. The syringe was filled with pure water, and pressure was applied to the plunger while observing the joined needle-like body 1 with a stereomicroscope. As a result, it was confirmed that pure water was injected from the middle part of the joined needle-like body 1. At this time, the leakage from the connection part with the joining board | substrate part 2 or a ricinji was not confirmed.

以上の結果から、作製した針状体アレイ内部の中空構造部が流路として機能していることを確認することができた。   From the above results, it was confirmed that the hollow structure portion inside the produced needle-like body array functions as a flow path.

本発明の製造方法で得られた中空針状体は、医療のみならず、微細な針状体を必要とする様々な分野に適用可能である。中空針状体は、例えば半導体デバイス、光学素子、配線回路、記録デバイス(ハードディスクやDVDなど)、医療検査用チップ(DNA分析用途など)、ディスプレイパネル、マイクロ流路、マイクロリアクタ、MEMSデバイス、検査機器のプローブ先端部、電界放出素子、創薬、化粧品などの製造工程において好適に利用することが期待できる。   The hollow needle-like body obtained by the production method of the present invention is applicable not only to medical treatment but also to various fields that require fine needle-like bodies. The hollow needle-shaped body is, for example, a semiconductor device, an optical element, a wiring circuit, a recording device (such as a hard disk or a DVD), a medical test chip (such as a DNA analysis application), a display panel, a microchannel, a microreactor, a MEMS device, or a test device. It can be expected to be suitably used in the manufacturing process of probe tips, field emission devices, drug discovery, cosmetics and the like.

Claims (17)

内部に中空部を有する中空針状体を製造する方法であって、
表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材を作製する工程と、
前記第1の針状体基材の溝を含む面を被覆部材で覆う工程と
を含み、
前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成する第2の針状体基材であり、
前記第1の針状体基材および前記第2の針状体基材の夫々は、針状体部と、前記針状体部をその基底部において保持する基板部とを備え、
前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、
中空針状体の製造方法。
A method for producing a hollow needle-like body having a hollow portion therein,
Producing a first needle-like body base material having a groove forming at least a part of the hollow portion on the surface;
Covering the surface including the groove of the first acicular substrate with a covering member ;
Only including,
The covering member is a second acicular body base material that constitutes the hollow acicular body in combination with the first acicular body base material,
Each of the first acicular body base and the second acicular body base includes a acicular body portion and a substrate portion that holds the acicular body portion at a base portion thereof,
The groove of the first acicular body base is formed in the acicular body portion and the substrate portion, and the groove of the substrate portion is connected to the groove of the acicular body portion;
A method for producing a hollow needle-like body.
前記第2の針状体基材は、前記第1の針状体基材の溝の一部を覆う、請求項1記載の中空針状体の製造方法。 The method for manufacturing a hollow needle-shaped body according to claim 1 , wherein the second needle-shaped body base material covers a part of a groove of the first needle-shaped body base material . 前記第2の針状体基材は、前記第1の針状体基材の溝と合わせて前記中空部を構成する溝を有する、請求項1記載の中空針状体の製造方法。 The method for manufacturing a hollow needle-shaped body according to claim 1 , wherein the second needle-shaped body base material has a groove that forms the hollow portion together with the groove of the first needle-shaped body base material . 前記第1の針状体基材及び前記第2の針状体基材の夫々は、複数の針状体部が1つの基板部に一列に配列して保持された構造を有し、前記第1の針状体基材及び前記第2の針状体基材を用いて1列に配列された複数の中空針状体を得る、請求項記載の中空針状体の製造方法。 Each of the first acicular body substrate and the second acicular body substrate has a structure in which a plurality of acicular body portions are held in a row on a single substrate portion, obtaining a plurality of hollow needle-like bodies arranged in a row with one needle base body and the second needle-like base material, manufacturing method of hollow needles according to claim 1, wherein. 請求項1記載の方法により製造された中空針状体を複数準備する工程と、前記各針状体の基板部を連結する工程とを含む、中空針状体の製造方法。 A method for producing a hollow needle-like body, comprising a step of preparing a plurality of hollow needle-like bodies produced by the method according to claim 1 and a step of connecting a substrate portion of each needle-like body . 前記第1の針状体基材及び前記第2の針状体基材を組み合わせる際のそれぞれの基板部の連結面の連結位置を合わせるための嵌め合わせ用凹凸構造を基板部に加工する工程をさらに含む請求項記載の中空針状体の製造方法。 Processing the fitting uneven structure for matching the connection positions of the connection surfaces of the respective substrate portions when combining the first acicular substrate and the second acicular substrate into the substrate portion; method for producing a hollow needle-like member according to claim 1 comprising further. 内部に中空部を有する中空針状体を製造する方法であって、
表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材を作製する工程と、
前記第1の針状体基材の溝を含む面を被覆部材で覆う工程と、
を含み、
前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成するシート状部材であり、
前記第1の針状体基材は、針状体部と、前記針状体部をその基底部において保持する基板部とを備え、
前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、
中空針状体の製造方法。
A method for producing a hollow needle-like body having a hollow portion therein,
Producing a first needle-like body base material having a groove forming at least a part of the hollow portion on the surface;
Covering the surface including the groove of the first acicular substrate with a covering member;
Including
The covering member is a sheet-like member that constitutes the hollow needle-like body in combination with the first needle-like body base material,
The first acicular body base includes an acicular body portion and a substrate portion that holds the acicular body portion at a base portion thereof,
The groove of the first acicular body base is formed in the acicular body portion and the substrate portion, and the groove of the substrate portion is connected to the groove of the acicular body portion;
A method for producing a hollow needle-like body.
前記第1の針状体基材および前記被覆部材は、生分解性材料からなる請求項1または7記載の中空針状体の製造方法。 The method for producing a hollow needle-shaped body according to claim 1 or 7, wherein the first needle-shaped body substrate and the covering member are made of a biodegradable material . 少なくとも前記第1の針状体基材の溝の表面に表面処理を施す工程をさらに含む請求項1または7記載の中空針状体の製造方法。 The method for producing a hollow needle-like body according to claim 1 or 7 , further comprising a step of performing a surface treatment on at least a surface of the groove of the first needle-like body base material . 中空部を有する針状体部を備える中空針状体であって、
表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材と、
前記第1の針状体基材の溝を含む面を覆う被覆部材と、
を備え、
前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成する第2の針状体基材であり、
前記第1の針状体基材および前記第2の針状体基材の夫々は、針状体部と、前記針状体部をその基底部において保持する基板部と、を備え、
前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、
中空針状体。
A hollow needle-like body comprising a needle-like body portion having a hollow part,
A first acicular body base material having a groove constituting at least a part of the hollow portion on the surface;
A covering member covering a surface including the groove of the first acicular body base;
With
The covering member is a second acicular body base material that constitutes the hollow acicular body in combination with the first acicular body base material,
Each of the first needle-like body base material and the second needle-like body base material includes a needle-like body portion and a substrate portion that holds the needle-like body portion at a base portion thereof,
The groove of the first acicular body base is formed in the acicular body portion and the substrate portion, and the groove of the substrate portion is connected to the groove of the acicular body portion;
Hollow needle-like body.
前記第2の針状体基材は、前記第1の針状体基材の溝の一部を覆う、請求項10記載の中空針状体。The hollow acicular body according to claim 10, wherein the second acicular body base material covers a part of a groove of the first acicular body base material. 前記第2の針状体基材は、前記第1の針状体基材の溝と合わせて前記中空部を構成する溝を有する、請求項10記載の中空針状体。The hollow acicular body according to claim 10, wherein the second acicular body substrate has a groove that forms the hollow portion together with the groove of the first acicular body substrate. 前記第1の針状体基材及び前記第2の針状体基材の夫々は、複数の針状体部が1つの基板部に一列に配列して保持された構造を有し、前記第1の針状体基材及び前記第2の針状体基材を用いて1列に配列された複数の中空針状体を得る、請求項10記載の中空針状体。 Each of the first acicular body substrate and the second acicular body substrate has a structure in which a plurality of acicular body portions are held in a row on a single substrate portion, The hollow needlelike object according to claim 10 which obtains a plurality of hollow needlelike objects arranged in a line using one needlelike object base material and the 2nd needlelike object base material . 中空部を有する針状体部を備える中空針状体であって、
表面に前記中空部の少なくとも一部を構成する溝を有する第1の針状体基材と、
前記第1の針状体基材の溝を含む面を覆う被覆部材と、
を備え、
前記被覆部材は、前記第1の針状体基材と組み合わせて前記中空針状体を構成するシート部材であり、
前記第1の針状体基材は、針状体部と、前記針状体部をその基底部において保持する基板部と、を備え、
前記第1の針状体基材の前記溝は前記針状体部及び前記基板部に形成されていて、前記基板部の前記溝は前記針状体部の前記溝に連結されている、
中空針状体。
A hollow needle-like body comprising a needle-like body portion having a hollow part,
A first acicular body base material having a groove constituting at least a part of the hollow portion on the surface;
A covering member covering a surface including the groove of the first acicular body base;
With
The covering member is a sheet member that constitutes the hollow needle-like body in combination with the first needle-like body base material,
The first acicular body base material includes a acicular body portion and a substrate portion that holds the acicular body portion at a base portion thereof,
The groove of the first acicular body base is formed in the acicular body portion and the substrate portion, and the groove of the substrate portion is connected to the groove of the acicular body portion;
Hollow needle-like body.
前記第1の針状体基材および前記被覆部材は、生分解性材料からなる請求項10または14記載の中空針状体。 The hollow needlelike object according to claim 10 or 14, wherein the first needlelike substance base and the covering member are made of a biodegradable material . 少なくとも前記第1の針状体基材の溝の表面に表面処理が施されている請求項10または14記載の中空針状体。 The hollow needlelike object according to claim 10 or 14 , wherein a surface treatment is applied to at least a surface of a groove of the first needlelike object substrate . 請求項10乃至16の何れか1項に記載の中空針状体と、この中空針状体の中空部に連結された液体の押し出し手段および吸引手段の少なくとも一方の手段と、を具備する中空針状体送液システム。A hollow needle comprising the hollow needle-like body according to any one of claims 10 to 16, and at least one of a liquid pushing means and a suction means connected to a hollow portion of the hollow needle-like body. Liquid feeding system.
JP2013540732A 2011-10-28 2012-10-16 Hollow needle-like body manufacturing method, hollow needle-like body and hollow needle-like body liquid feeding system Active JP6119609B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011236979 2011-10-28
JP2011236979 2011-10-28
PCT/JP2012/076696 WO2013061825A1 (en) 2011-10-28 2012-10-16 Hollow needles manufacturing method and hollow needles

Publications (2)

Publication Number Publication Date
JPWO2013061825A1 JPWO2013061825A1 (en) 2015-04-02
JP6119609B2 true JP6119609B2 (en) 2017-04-26

Family

ID=48167658

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2013540732A Active JP6119609B2 (en) 2011-10-28 2012-10-16 Hollow needle-like body manufacturing method, hollow needle-like body and hollow needle-like body liquid feeding system

Country Status (6)

Country Link
US (1) US9533131B2 (en)
EP (1) EP2772279B1 (en)
JP (1) JP6119609B2 (en)
KR (1) KR101635292B1 (en)
CN (1) CN103889499B (en)
WO (1) WO2013061825A1 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6430501B2 (en) * 2013-07-16 2018-11-28 スリーエム イノベイティブ プロパティズ カンパニー Hollow microneedle with beveled opening
WO2015009524A1 (en) 2013-07-16 2015-01-22 3M Innovative Properties Company Hollow microneedle with beveled tip
EP3021931B1 (en) 2013-07-16 2021-09-01 Kindeva Drug Delivery L.P. Hollow microneedle array article
SG11201600330XA (en) 2013-07-16 2016-02-26 3M Innovative Properties Co Article comprising a microneedle
AU2015250841A1 (en) * 2014-04-25 2016-10-27 Sanofi New administration routes of insulin, insulin analogs or derivatives of insulin
CN104117137B (en) * 2014-07-08 2017-12-15 清华大学 Unloaded medicine microneedle array and preparation method thereof in a kind of capsule-type
JP7051815B2 (en) * 2017-03-31 2022-04-11 Asti株式会社 Microneedle array and microneedle array manufacturing method
JP1601442S (en) * 2017-07-28 2018-04-09
TW202143917A (en) * 2020-02-11 2021-12-01 瑞典商艾瑟莉恩公司 A microneedle and a fluid channel system for collecting fluid

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3964482A (en) 1971-05-17 1976-06-22 Alza Corporation Drug delivery device
BE795384A (en) 1972-02-14 1973-08-13 Ici Ltd DRESSINGS
US20080004597A1 (en) 2001-12-08 2008-01-03 Lattouf Omar M Methods and devices for endocardiac access
US7312396B1 (en) 2004-03-13 2007-12-25 Protectconnect, Inc. Universal electrical wiring component
KR100784848B1 (en) * 2005-12-09 2007-12-14 한국생산기술연구원 microneedle for injection molding
EP2036586B1 (en) 2006-07-04 2015-09-09 Toppan Printing Co., Ltd. Method for manufacturing microneedle
US7400506B2 (en) 2006-07-11 2008-07-15 Dell Products L.P. Method and apparatus for cooling a memory device
WO2008013282A1 (en) 2006-07-27 2008-01-31 Toppan Printing Co., Ltd. Method for producing microneedle
WO2008020632A1 (en) 2006-08-18 2008-02-21 Toppan Printing Co., Ltd. Microneedle and microneedle patch
WO2008093679A1 (en) 2007-01-29 2008-08-07 Medrx Co., Ltd. Process for producing microneedle of thermosensitive substance
JP4978243B2 (en) * 2007-03-06 2012-07-18 凸版印刷株式会社 Needle-like body and method for producing needle-like body
JP2008284318A (en) * 2007-05-15 2008-11-27 Kosumedei Seiyaku Kk Microneedle for dosing, including living body origin matter
KR100911488B1 (en) * 2007-09-07 2009-08-11 호남석유화학 주식회사 Micro needle and micro needle array
JP5120624B2 (en) * 2008-01-31 2013-01-16 芳一 飛永 Fine sugar needle, manufacturing method and manufacturing apparatus
CN101342404B (en) * 2008-08-28 2010-04-14 上海交通大学 Method for manufacturing different-plane metal hollow fine needle for transdermal drug administration
KR101004014B1 (en) * 2008-12-18 2010-12-31 (주)마이티시스템 Structure of a Micro-needle with a Side Channel, and Manufacturing Method of the Same
US20110021996A1 (en) * 2008-12-18 2011-01-27 Miti Systems Inc. Structure of micro-needle with side channel and manufacturing method thereof
KR101033514B1 (en) * 2009-06-02 2011-05-09 (주)마이티시스템 Flexible Patch System with Micro-needle, and Manufacturing Method of the Same
JP2011078654A (en) * 2009-10-09 2011-04-21 Asti Corp Microneedle array and method of manufacturing microneedle array
JP5805376B2 (en) 2010-06-29 2015-11-04 Asti株式会社 Microneedle array and microneedle array manufacturing method

Also Published As

Publication number Publication date
EP2772279B1 (en) 2019-06-05
WO2013061825A1 (en) 2013-05-02
KR101635292B1 (en) 2016-06-30
KR20140079862A (en) 2014-06-27
EP2772279A4 (en) 2015-12-16
CN103889499B (en) 2017-03-08
US9533131B2 (en) 2017-01-03
JPWO2013061825A1 (en) 2015-04-02
CN103889499A (en) 2014-06-25
EP2772279A1 (en) 2014-09-03
US20140236075A1 (en) 2014-08-21

Similar Documents

Publication Publication Date Title
JP6119609B2 (en) Hollow needle-like body manufacturing method, hollow needle-like body and hollow needle-like body liquid feeding system
CA2491839C (en) A method of forming a mold and molding a micro-device
JP4709363B2 (en) Parts manufacturing method and apparatus
JP5860453B2 (en) Composite microneedle array with nanostructures on the surface
EP2416835B1 (en) Methods of making hollow microneedle arrays
US20070191761A1 (en) Method of molding for microneedle arrays
JP2010502267A (en) Microneedle and method for producing microneedle
KR20150102070A (en) Article with hollow microneedles and method of making
US10799691B2 (en) Needle assembly for transdermal administration and method of producing the same
US20170120027A1 (en) Microneedle and microneedle assembly
US20090171314A1 (en) Molded articles comprising microneedle arrays
WO2018181639A1 (en) Microneedle array and production method for microneedle array
JP2011078654A (en) Microneedle array and method of manufacturing microneedle array
KR102235084B1 (en) Method for manufacturing a micro-needle master with high aspect ratio
CN115227957A (en) Method for preparing hollow microneedle and product thereof
CN115227956A (en) Preparation method of hollow microneedle
KR20110121244A (en) Hollow type microneedle for easy mass production and manufacturing method thereof
Imai et al. Microneedle of biodegradable polyacid anhydride with a capillary open groove for reagent transfer
CN115003364A (en) Mold element for making microstructures
JP2018121842A (en) Method for manufacturing needle-like body

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20150918

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160719

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160912

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20170228

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20170313

R150 Certificate of patent or registration of utility model

Ref document number: 6119609

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250